BQ_-_14_-_Summer_2014

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on hold, such as the relocation of a lab support
facility and balanced scorecard implementation.
The compliance projects to address the warning
letter were then themselves prioritized.
When the FDA came for their follow-up site
visit, management now had a list of projects
demonstrating exactly how they would address
every one of the agency’s concerns.
Recipe for Disaster
During his initial interviews with the team, the
project manager quickly realized they were all
rushing toward a cliff. The bulk of the compliance
work was planned to take place during the facility’s
usual summer shutdown. The plant would cease
operations to replace several systems and make
other major fixes, so the timing was ideal. But the
scope of each project was enormous, comprised of
huge lists developed in concert with the corporate
regulatory and quality groups. The project manager
asked the facility team if they’d be able to get all
activities done in the time allotted. The answer:
an unequivocal “no.” But the corporate message
had been “get it done.” No excuses. So the team
committed to doing it, and they’d give it their best
shot.
Evidence-based Solution
To skirt catastrophe, the project manager worked
with the facility team to develop three scenarios:
• Scenario #1: The “schedule” scenario assumed
the facility must complete as much as its
compliance work within the designated summer
shutdown period as possible. Given the
current project scope, what activities would the
team have to remove to provide 100 percent
confidence they could meet the schedule? Result:
They would have to eliminate so many activities
and thus would accomplish so little that they’d
meet none of the regulatory objectives. The FDA
could shut them down.
BioLogical Quarterly Summer 2014
• Scenario #2: The “full scope” scenario was at
the other end of the spectrum. If the team were to
perform every single activity on the project list,
how long would it take? Result: As expected,
it would take many months more than the FDA
would accept and than the business could
maintain supply continuity.
• Scenario #3: The “balanced” scenario was
prioritized based on the regulatory viewpoint.
What were the absolute “must haves” that would
satisfy the FDA’s requirements and prevent a plant
shutdown? What could they wait to do later?
The team assembled that list, and projects were
prioritized into tiers. Next: How long would
it take to perform these projects? Calculations
showed that the shutdown would start slightly
later and last slightly longer than the original
summer shutdown timetable, but the facility could
build up adequate inventory in advance, and
they’d meet the FDA’s timetable.
Building the three scenarios took almost a full
month: gathering data, developing detailed
schedules and identifying resource requirements. It
was time well spent. All scenarios were presented to
corporate management, with the third “balanced”
scenario as the team’s recommendation. The official
corporate response: “It’s a no brainer.”
Tightly Integrated, Fully Orchestrated
To stay within the “balanced” scenario schedule,
every activity had to be carefully coordinated.
The original plan had included four projects. They
were integrated into a single program, led by one
program leader and four sub-project team leads.
The overarching plan had to be extremely detailed
in terms of timing, handoffs and sequential and
parallel activities. Otherwise, at some point,
20 people would suddenly converge into
a five-by-five-foot space to work.
“To stay within the ‘balanced’ scenario
schedule, every activity had to be
carefully coordinated.”
During execution, the program leader and project
managers stayed close to their teams to ensure they
had what they needed to meet the schedule every
day, problem-solving as necessary to keep the
projects on track. Due to frequent communications,
facility and corporate management remained fully
in sync throughout.
Outcome
The facility met its targets, the warning letter
was lifted and a shutdown was avoided.
The organization as a whole improved its ability
to plan and execute complex projects. And the
corporate culture evolved to keep more ahead
of the curve on regulatory compliance.
Tackling difficult
compliance issues is
not easy. But a processdriven
approach provides
an objective framework for
regulatory success.
No missed deadlines.
No failed requirements.
Plenty of matches. BQ
“The facility met its targets, the warning
letter was lifted and a shutdown was
avoided. The organization as a whole
improved its ability to plan and execute
complex projects.”
Editor’s Note: This article originally appeared in
PharmaVOICE.
BioLogical Quarterly thanks PharmaVOICE for permitting the
republication of Greg Kain’s essay.
Integrated Project Management Company (IPM) is a project
management consulting firm that specializes in the life
sciences industry. Areas of company expertise include
product development, alliance management, business process
improvement, technology transfer, regulatory compliance and
quality assurance. Headquartered in Chicago, IPM has offices
in San Francisco, St. Louis and Boston. Visit ipmcinc.com or
call 630-789-8600. Contact Greg at gkain@ipmcinc.com.
Implementing IPM’s principles can have a calming effect on your organization.
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